Drugs

OTC Drug Reform Passes Senate

The Senate voted 12/10 to approve on a 91-2 vote S. 2740, the Over-the-Counter Drug Safety, Innovation, and Reform Act, which its sponsors say will streamline and modernize FDA’s regulatory system. A statement from Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) says the bill would:

change the “cumbersome” monograph rulemaking process to an administrative order process such as used for other medical product approvals;
allow the HHS secretary to take rapid action to protect public health in the event of safety issues;
establish processes for manufacturers to request administrative orders, or for the HHS secretary to initiate administrative orders at the recommendation of FDA or in response to citizens’ petitions;
establish a process by which drug developers can request meetings with FDA similar to existing processes for prescription drug development;
create a new incentive to bring innovative over-the-counter products to consumers by providing an 18-month period of product exclusivity to reward innovation;
require an annual update to Congress on FDA evaluation of the cold and cough monograph with respect to children under age six; and
authorize FDA to collect user fees to provide the necessary resources to evaluate and monitor the over-the-counter market.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome